Trials / Completed
CompletedNCT01150643
Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab
Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 559 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. It may also help doctors identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.
Detailed description
OBJECTIVES: * Correlate immunoglobulin Fc receptor (FcγR) polymorphisms with response, response duration, and time to resistance in samples from patients with follicular lymphoma (FL) treated with single-agent rituximab on ECOG-E4402. * Identify gene expression profiles that correlate with response, response duration, and time to rituximab resistance in these patients. * Determine whether the FL microenvironment is predictive of initial response and duration of response to rituximab. OUTLINE: DNA and RNA from banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples are analyzed for immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma microenvironment by real-time PCR, microarray hybridization, and IHC. PROJECTED ACCRUAL: A total of 259 PBMC samples and 300 FFPE blocks will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | gene expression analysis | |
| GENETIC | microarray analysis | |
| GENETIC | polymerase chain reaction | |
| GENETIC | polymorphism analysis | |
| OTHER | immunohistochemistry staining method | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2010-12-06
- Primary completion
- 2011-01-06
- Completion
- 2011-01-06
- First posted
- 2010-06-25
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT01150643. Inclusion in this directory is not an endorsement.